Meniscus LesionPhase 2/3ProlotherapyNCT03066583
Effectiveness of Trephination With Platelet Rich Plasma or Placebo in a Primary Meniscal Tear Treatment
A Phase 2/3 study testing trephination with platelet rich plasma in people with Meniscus Lesion, run by Centre of Postgraduate Medical Education at 1 site in Poland.
Trial summary
This study will compare meniscal healing augmented or without augmentation with platelet rich plasma in primary meniscal tear treatment (prolotherapy). The assessments will include validated, disease specific, patient oriented outcome measures. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Meniscus Lesion
- What is being tested?
- trephination with platelet rich plasma
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 sitePoland
- Study dates
- Jan 2016to Jun 2020
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Complete horizontal 10 mm in length
- Tear located in the vascular/avascular portion of the meniscus (chronic horizontal tear on MR)
- Single tear of the medial and/or lateral meniscus
- Skeletally mature patients 18-70 years of age
Who cannot join
- discoid meniscus
- arthritic changes (Kellgren Lawrence scale >2) or axial leg deformity (valgus > 6 deg)
- inflammatory diseases (i.e. rheumatoid arthritis)
- concominant chondral defects (> 2 ICRS)
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of Orthopaedics and Traumatology, Postgraduate Center for Medical Education, Professor A. Gruca Teaching Hospital
Otwock, Masovian Voivodeship, 05-400
About this study
Official title: Prospective, Randomised, Double Blinded Trial Comparing Effectiveness of Platelet Rich Plasma or Placebo in a Primary Meniscal Tear Treatment
This study will compare meniscal healing augmented or without augmentation with platelet rich plasma in primary meniscal tear treatment (prolotherapy). The assessments will include validated, disease specific, patient oriented outcome measures. Results of this study will help ascertain whether platelet rich plasma may improve meniscal healing rates.
Read the detailed description
The role of meniscal in the knee integrity is pivotal and lack or partial role of the meniscus increases rate of joint degeneration. Partial meniscal removal is the most popular procedure and meniscal repair remain in minority of arthroscopic surgeries. As criteria of inclusion to meniscal repair are very rough, still success rates of meniscal repair remain in the 60-80% range for isolated repairs. This rate is greater when performed with ACL reconstruction. The investigators believe that augmentation with platelet rich plasma as prolotherapy ill induce healing without the need for arthroscopy.
- Conditions
- Meniscus Lesion
- Being tested
- trephination with placebo, trephination with platelet rich plasma
- Keywords
- meniscus repair, platelet rich plasma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
trephination with placeboBiological
trephination under US guidance and placebo injection
trephination with platelet rich plasmaBiological
trephination under US guidance and platelet rich plasma injection
| Study group | Role | What they receive |
|---|---|---|
| trephination with placebo | Placebo comparator | meniscal repair with trephination and placebo Receives: Biological: trephination with placebo |
| trephination with platelet rich plasma | Experimental | meniscal repair with trephination and platelet rich plasma Receives: Biological: trephination with platelet rich plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of meniscal healing by MR scanning
The primary outcome measures will be assessment of meniscal healing integrity by MR scanning
Measured: by 1 year
Secondary outcomes (3)
Visual Analog Scale
Pain Visual Analog Scale.
Measured: 12 weeks, 6months, 1year post procedure
Knee injury and Osteoarthritis Outcome Score scale
Knee injury and Osteoarthritis Outcome Score
Measured: 12 weeks, 6months, 1year post procedure
International Knee Documentation Committee - Subjective Knee Evaluation Form
International Knee Documentation Committee - Subjective Knee Evaluation Form
Measured: 12 weeks, 6months, 1year post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2017
- Study startJan 2016
- Primary completionJan 2019
- Study completionJun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meniscus LesionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre of Postgraduate Medical Education
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rafał Kamiński, Centre of Postgraduate Medical Education
- Investigators
- Rafal Kaminski, Principal investigator, PCME, Otwock, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03066583
- Sponsor's protocol ID
- 501-1-07-18-15
- Acronym
- Prolotherapy
- Status last verified
- Jun 2020
- First submitted
- 21 Oct 2016
- Last updated
- 2 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomised, Double Blinded Trial Comparing Effectiveness of Platelet Rich Plasma or Placebo in a Primary Meniscal Tear Treatment
- ClinicalTrials.gov ID
- NCT03066583
- Acronym / sponsor ID
- Prolotherapy / 501-1-07-18-15
- Conditions
- Meniscus Lesion
- Keywords
- meniscus repair, platelet rich plasma
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Centre of Postgraduate Medical EducationUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Jan 2019 (actual)
- Study completion
- Jun 2020 (actual)
- First posted
- 28 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will compare meniscal healing augmented or without augmentation with platelet rich plasma in primary meniscal tear treatment (prolotherapy). The assessments will include validated, disease specific, patient oriented outcome measures. Results of this study will help ascertain whether platelet rich plasma may improve meniscal healing rates.
Detailed description
The role of meniscal in the knee integrity is pivotal and lack or partial role of the meniscus increases rate of joint degeneration. Partial meniscal removal is the most popular procedure and meniscal repair remain in minority of arthroscopic surgeries. As criteria of inclusion to meniscal repair are very rough, still success rates of meniscal repair remain in the 60-80% range for isolated repairs. This rate is greater when performed with ACL reconstruction. The investigators believe that augmentation with platelet rich plasma as prolotherapy ill induce healing without the need for arthroscopy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| trephination with placebo | Placebo comparator | Biological: trephination with placebomeniscal repair with trephination and placebo |
| trephination with platelet rich plasma | Experimental | Biological: trephination with platelet rich plasmameniscal repair with trephination and platelet rich plasma |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Complete horizontal 10 mm in length
- Tear located in the vascular/avascular portion of the meniscus (chronic horizontal tear on MR)
- Single tear of the medial and/or lateral meniscus
- Skeletally mature patients 18-70 years of age
Key exclusion criteria (4 listed)
- discoid meniscus
- arthritic changes (Kellgren Lawrence scale >2) or axial leg deformity (valgus > 6 deg)
- inflammatory diseases (i.e. rheumatoid arthritis)
- concominant chondral defects (> 2 ICRS)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| trephination with placebotrephination under US guidance and placebo injection | Biological | trephination with placebo |
| trephination with platelet rich plasmatrephination under US guidance and platelet rich plasma injection | Biological | trephination with platelet rich plasma |
Primary outcome
Assessment of meniscal healing by MR scanning
Time frame: by 1 year
The primary outcome measures will be assessment of meniscal healing integrity by MR scanning
3 secondary outcomes
Visual Analog Scale
Time frame: 12 weeks, 6months, 1year post procedure
Knee injury and Osteoarthritis Outcome Score scale
Time frame: 12 weeks, 6months, 1year post procedure
International Knee Documentation Committee - Subjective Knee Evaluation Form
Time frame: 12 weeks, 6months, 1year post procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rafal Kaminski principal investigator
PCME, Otwock, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing trephination with platelet rich plasma in people with Meniscus Lesion, run by Centre of Postgraduate Medical Education at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of meniscal healing by MR scanning (time frame: by 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2020.